UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004167
Receipt number R000005001
Scientific Title Efficacy of aprepitant on postoperative nausea and vomiting: Assesement with patient-controlled prevention of nause and vomiting (PCPNV).
Date of disclosure of the study information 2010/09/07
Last modified on 2013/03/21 09:57:51

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Basic information

Public title

Efficacy of aprepitant on postoperative nausea and vomiting: Assesement with patient-controlled prevention of nause and vomiting (PCPNV).

Acronym

Aprepitant inhibits PONV

Scientific Title

Efficacy of aprepitant on postoperative nausea and vomiting: Assesement with patient-controlled prevention of nause and vomiting (PCPNV).

Scientific Title:Acronym

Aprepitant inhibits PONV

Region

Japan


Condition

Condition

Patients undergoing dento-oral surgery

Classification by specialty

Anesthesiology Operative medicine Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy of NK-1 receptor antagonist on PONV

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Consumption of postoperative anti-emetic agent

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Aprepitant 125 mg was preoperatively administered in 20 patients undergoing oro-dental-surgeries and postoperative neusea and vomiting is evaluated.

Interventions/Control_2

Metoclopramide 10 mg was administered just before completion fo surgery in 20 patients undergoing oro-dental-surgeries and postoperative neusea a vomiting is evaluated. Preoperative administration of metoclopramide

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

40 years-old >

Gender

Male and Female

Key inclusion criteria

Patients for surgical correction of bite

Key exclusion criteria

Patients with pregnancy, having vomiting with 24 h before surgery in any etiology, allergy to any medications to be used prtioperatively, hepatic and renal disfunction.
Patients taking medications known to induce or inhibit cytochrome P-450 3A4.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiji Masaki

Organization

Tohoku University Graduate School of Dentistry

Division name

Division of Dento-oral Anesthesiology

Zip code


Address

4-1 Seiryou-machi, Aoba-ku, Sendai, Miyagi

TEL

022-717-8401

Email



Public contact

Name of contact person

1st name
Middle name
Last name Syomu

Organization

Tohoku University Graduate School of Dentistry

Division name

Syomu

Zip code


Address


TEL


Homepage URL


Email

den-syomu@bereau.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Graduate School of Dentistry

Institute

Department

Personal name



Funding Source

Organization

Tohoku University Graduate School of Dentistry

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 07 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2010 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 09 Month 07 Day

Last modified on

2013 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005001


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name